This working group’s main task is to have a close look at the current status quo in order to define what is needed to gain approval for 3D-printed medical devices and to establish them in the industry.

This working group’s main task is to have a close look at the current status quo in order to define what is needed to gain approval for 3D-printed medical devices and to establish them in the industry.
European Medical Device Regulation (MDR): Converting old standards into new standards (norms, liability, certification)
Jointly overcoming regulatory hurdles in the certification process
Leveraging know-how transfer by inviting specialists in MDR, quality management, end-to-end solutions, point-of-care manufacturing, cost management, etc.